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CompletedNCT01717261SPORTUpdated Nov 1, 2023

Single Pre-Operative Radiation Therapy (SPORT) for Low Risk Breast Cancer

A Phase 1 interventional study of Single Pre-Operative Radiation Therapy in Breast Cancer, sponsored by Maisonneuve-Rosemont Hospital. Completed at 1 site in Canada. Open to female participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2023-11-01.

Sponsored by Maisonneuve-Rosemont Hospital · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
60 Years and older
Sex
Female
01

Study summary

The purpose of this study is to determine if partial breast irradiation administered in a single preoperative fraction is tolerable.

02

Conditions studied

  • Breast Cancer

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Keywords

  • breast cancer
  • early breast cancer
  • partial breast irradiation
  • preoperative radiation
03

In context

Breast Neoplasms

12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.

This study's planned enrollment of 10 is below the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Maisonneuve-Rosemont Hospital is the lead sponsor of 73 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female aged 60 years or older.
  • Invasive ductal carcinoma.
  • Unifocal disease.
  • Tumors less than 2cm.
  • No clinical evidence of nodal disease.
  • Estrogen receptor status (ER) positive.
  • Her2 negative.

Exclusion criteria

Exclusion Criteria:

  • Age less than 60 years.
  • BRCA 1 and/or BRCA 2 mutation.
  • Tumour histology limited to lobular carcinoma only.
  • Neoadjuvant hormonal manipulation or chemotherapy.
  • More than one primary tumour in different quadrants of the same breast.
  • Inability to view tumor on imaging.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Single Pre-Operative Radiation Therapy

    Radiation: Single Pre-Operative Radiation Therapy

Interventions

  • RadiationSingle Pre-Operative Radiation Therapy

    Dose escalation: 3 patients will receive 15 Gy in a single fraction. The following 3 patients will receive 18 Gy. The final 4 patients will receive 20 Gy.

06

What researchers measure

Primary outcomes

  1. Acute toxicity

    Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale.

    Time frame: 6 months

Secondary outcomes

  1. Chronic toxicity

    Assess late-onset toxicity associated with a single fraction radiation treatement as per RTOG/EORTC Late Radiation Toxicity Scale

    Time frame: 2 years

  2. Cosmetic outcome

    Cosmesis will be evaluated as per the EORTC Breast Cancer Cosmetic Rating scale.

    Time frame: 5 years

Other outcomes

  1. Ipsilateral breast cancer recurrence

    Time frame: 5 years

07

Study locations

1 site
  • Maisonneuve-Rosemont Hospital
    Montreal, Quebec H1T 2M4, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01717261
Lead sponsor
Maisonneuve-Rosemont Hospital
Responsible party
Michael Yassa (Radiation Oncologist, Maisonneuve-Rosemont Hospital) — Principal investigator
First posted
Oct 30, 2012
Start date
Aug 2012
Primary completion
Dec 2018
Completion
Oct 2023
Last update
Nov 1, 2023

Study contacts

Michael Yassa, MD
study chair · Maisonneuve-Rosemon Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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